Comparison of risk and patient-related benefit of treatment with etanercept in elderly patients with rheumatoid arthritis

Comparison of risk and patient-related benefit of treatment with etanercept in elderly patients with rheumatoid arthritis - CORELA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00012590

Enrollment

130

Registered

2018-01-08

Start date

2012-07-11

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M06.99

Interventions

Group 1: Therapy start with Etanercept (ETA) 50mg1x/w or 25mg 2x/w s.c. Evaluation of quality of life, physical function, quality of sleep, fatique, pain, nutritional condition and social activity of

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: • Fulfilling of the DGRh criteria of treatment with ETA and/or DMARD or just begun (= 4 weeks) • The Diagnose of a Rheumatoid Arthritis according to ACR criteria from 1987 • = 60 years • Understanding the research project • Signing the informed consent form

Exclusion criteria

Exclusion criteria: • DGRh-criteria to start a therapy with biologicals are not fulfilled • There is an intra-articular injection with Glucocorticoids or other NSAIDs four weeks before screening • There is an intramuscular injection with Glucocorticoids (>10 mg prednisolone or equivalent) or other NSAIDs four weeks before screening • There is no signed inform consent • Other contraindication against the participation

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the evaluation of the long term effects in the treatment with ETA (mono therapy and in combination) in quality of life, fatigue, quality of sleep in elderly patients with a RA. The results will be evaluated with questionnaires in month 6 and 12 under the treatment.	—

Secondary

Measure	Time frame
• Change in food habits from T0 to T1 and T2 • change in disease activity by DAS28 and CDAI from T0 to T1 and T2 • change in functional capacity (HAQ) from T0 to T1 and T2 • change in emotional state from T0 to T1 and T2 • change in pain (pain detect) and visual analogue scale from T0 to T1 and T2 • change in ACR20, ACR50, ACR70 from T0 to T1 and T2	—

Countries

Germany

Contacts

Public ContactJacqueline Detert

Charité - Universitätsmedizin BerlinKlinik mS Rheumatologie und Klinische Immunologie

insider@charite.de+49 30 450 513 133

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026